Securities Code: 300199
Securities Abbreviation: Han's Pharmaceutical
Announcement No.: 2026-036
Shenzhen Han's Pharmaceutical Co., Ltd.
Announcement on the Acceptance of 2 ANDAs for Tirzepatide Injection for Diabetes and Weight Loss by US FDA as First Generic
The Company and all members of the Board of Directors guarantee that the information disclosed is true, accurate, and complete, and that there are no false records, misleading statements, or major omissions.
Recently, Shenzhen Han's Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") announced that its New Drug Application (ANDA) for Tirzepatide Injection (Tirzepatide Injection) submitted to the US Food and Drug Administration (hereinafter referred to as "FDA") has received an acceptance and review notice from the FDA. The FDA has preliminarily deemed this ANDA substantially complete and has accepted it for review. The relevant situation is hereby announced as follows:
I. Basic Product Information
Drug Name: Tirzepatide Injection
Dosage Form and Specifications: Single-dose pre-filled injection pen, with 6 specifications, including: 2.5 mg/0.5 mL (5 mg/mL), 5 mg/0.5 mL (10 mg/mL), 7.5 mg/0.5 mL (15 mg/mL), 10 mg/0.5 mL (20 mg/mL), 12.5 mg/0.5 mL (25 mg/mL), and 15 mg/0.5 mL (30 mg/mL)
Indications: For adult type 2 diabetes, weight loss (chronic weight management), and obstructive sleep apnea